The Pharmacist

DECEMBER 18, 2023

NHS England (NHSE) expects Covid-19 vaccines to become available for private purchase ‘in due course’, according to its newly published vaccine strategy. The document also revealed that the Department of Health and Social Care (DHSC) has ‘begun to facilitate conversations between manufacturers and providers to support this process’.

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Vaccines Documentation 82

Pharmafile

MAY 9, 2024

UK-based pharmaceutical company AstraZeneca has announced that is it voluntarily withdrawing its COVID-19 vaccine Vaxzevria due to a drop in global demand. The withdrawal also comes after AstraZeneca admitted in court documents that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS).

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Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 59

NY Times

JULY 30, 2021

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

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Documentation Vaccines Immunization Immunity 64

Express Pharma

AUGUST 23, 2023

The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus.

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Vaccines Documentation Immunity Immunization 95

European Pharmaceutical Review

DECEMBER 19, 2023

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

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Vaccines Communication Immunity Immunization 111

pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers.

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Vaccines Documentation 138

PharmaTech

OCTOBER 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

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Vaccines Documentation 52

pharmaphorum

MARCH 17, 2021

Germany has awarded a tender to a consortium led by IBM to develop a secure app that will provide a digital version of the country’s paper vaccine certificates. IBM has already developed a Digital Health Pass that is being trialled in the US as a health passport, capturing COVID-19 test results, temperature scans and vaccine records.

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Vaccines Documentation 144

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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Documentation Vaccines 113

European Pharmaceutical Review

NOVEMBER 18, 2022

The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries.

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Vaccines Immunity Immunization Documentation 98

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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Vaccines Adverse Reactions Documentation Immunity 111

STAT

JULY 18, 2024

Europe’s second-highest court criticized the European Commission for a lack of transparency over Covid-19 vaccine contracts four years ago , Reuters writes. The EC says she did not keep the messages. Continue to STAT+ to read the full story…

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Documentation Vaccines 257

pharmaphorum

DECEMBER 10, 2020

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.

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Vaccines Documentation 103

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

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Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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Vaccines Documentation 125

pharmaphorum

MARCH 2, 2021

Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over.

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Vaccines Adverse Reactions Documentation Labelling 119

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

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Vaccines Drug Pricing Biosimilars Documentation 108

pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. The post US experts stress over safety of AZ’s COVID-19 vaccine appeared first on.

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Vaccines Documentation Immunity Immunization 105

pharmaphorum

JANUARY 13, 2021

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.

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Vaccines Documentation 82

pharmaphorum

JANUARY 28, 2022

The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

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Vaccines Documentation 64

NY Times

OCTOBER 4, 2021

The findings, which also document a waning of protection against infection, come as officials debate the necessity and timing of booster shots.

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Hospitals Documentation Vaccines Immunization 98

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. “The need for a preventive Nipah virus vaccine is significant,” he added.

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Vaccines Documentation Immunity Immunization 52

pharmaphorum

JUNE 29, 2022

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). They are however both based on the original BA.1 1 will be “already somewhat outdated.”

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Vaccines Immunity Immunization Documentation 52

Quality Matters

MAY 24, 2023

World Vaccine Congress 2023: Spotlight shines on mRNA and viral vectored technology platforms Interest in innovative vaccines that use messenger ribonucleic acid (mRNA) and viral vectored technologies was among the key draws at this year’s World Vaccine Congress (WVC) on April 3-6 in Washington, D.C.

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Vaccines Documentation Immunity Immunization 52

pharmaphorum

JANUARY 29, 2021

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. That’s in line with the conclusions of the MHRA, which approved the vaccine at the end of last year. Janssen shot 66% effective.

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Vaccines Documentation 64

Express Pharma

JUNE 20, 2023

The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Institutional support, such as expert consultants, essential document templates, and protocols for regulatory submissions, is also vital. However, the spotlight has shifted to unravelling the complexities of the human immune system.

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Immunization Immunity Vaccines Hospitals 105

European Pharmaceutical Review

JUNE 29, 2022

As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. To summarise, bioproduction hurdles include the necessity to be fast, agile and, not to be understated, able to deliver safe and effective vaccines worldwide. _4W2cWlEb439CWlu?startTime=1632749714000

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Vaccines Documentation 98

Eye on FDA

NOVEMBER 17, 2020

Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time.

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Communication Vaccines HIPAA Documentation 81

pharmaphorum

FEBRUARY 24, 2021

AstraZeneca has said it will be able to meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. However there is hope that vaccine production will be stepped up later on in the year, according to Reuters.

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Vaccines Documentation 64

PharmaTech

MAY 18, 2023

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

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Documentation Vaccines 40

Pharma Pathway

JANUARY 30, 2023

It Specialises in the areas of low-cost Vaccine Production. Manufacturing Vaccines (Drug Substances): Antigen Manufacturing Officer Department: Manufacturing Position: Officer Qualification: B.Sc Execution of documentation activities of liaison with QA & QC for GMP Compliance.

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Documentation Vaccines 66

pharmaphorum

JULY 14, 2022

The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

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Documentation Vaccines 52

STAT

JUNE 9, 2023

In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Pfizer developed a vaccine that, if approved, will be given in pregnancy. Track the meeting here and here. The drug was developed by AstraZeneca, and will be marketed in the U.S. Continue to STAT+ to read the full story…

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Documentation Vaccines 246

pharmaphorum

MAY 3, 2022

. “From the beginning of the pandemic, we noted inequities in the way the US population was experiencing disease incidence – the cases of COVID and the access to testing, level of clinical services available, and, when the vaccine became available, differential levels of access to the vaccine,” Labrique says.

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Vaccines Documentation 105

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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Packaging Vaccines Documentation 105

European Pharmaceutical Review

NOVEMBER 9, 2022

Within recent years this situation has been further exacerbated by the COVID-19 pandemic: both directly, through viral vaccine manufacture; and indirectly, through instability in global supply chains. Those available commercially include adenoviral-based vaccines by AstraZeneca and Johnson & Johnson. References. Globaldata.com.

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Vaccines Documentation Communication Hospitals 115

pharmaphorum

FEBRUARY 25, 2021

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. S vaccine – developed by J&J’s Janssen Biotech unit – is “consistent” with recommendations in its EUA guidance for COVID-19 vaccines.

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Vaccines Documentation 59